BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2971039 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-15207
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15206. THE PT HAS TWO LEADS (FROM DIFFERENT LOTS) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED SUBSEQUENT TO A FALL, THE PT EXPERIENCED STABBING AND PIERCING PAIN NEAR THE LEAD INSERTION SITE. THE PT INDICATES, SHE STOPPED USING HER SCS SYSTEM DUE TO THE PAIN. X-RAYS WERE ORDERED AND INDICATED THE RIGHT LEAD (IT IS UNK WHICH OF THE TWO IMPLANTED LEADS IS THE RIGHT, BOTH ARE BEING REPORTED) HAD MIGRATED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69370 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3648541

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)